SAJEEV,
The information:
[1] FDA 510(k) K982826.
[2] Mega 2000 Patient Return Electrode System Theory of Operation.
[3] Recommended Practices for Electrosurgery AORN Journal, March 2005, Vol 81, No3.
Given in the top link, above, was actually taken off their own website - in support of the argument to think carefully before using this type of product.
In the EU, it's the user that's responsible for the correct use and application of return electrodes not necessarily the manufacturer of ESUs or return-electrodes.
